Lubricating deodorant for ostomy pouches

ABSTRACT

A lubricating deodorant for ostomy pouches in the form of an aqueous solution which contains both a water-soluble lubricating agent and a compatible water-soluble complexing agent capable of complexing with and neutralizing the odor-causing molecules of fecal matter. Other surfactants, preservatives, humectants and pH-adjusting agents may also be included. The method of using such a lubricating deodorant solution is also disclosed.

BACKGROUND AND SUMMARY

Deodorizing compositions for use in ostomy pouches are known in the artas disclosed, for example, in U.S. Pat. No. 6,129,716 (Steer) and U.S.Pat. No. 6,200,939 (Maurer). They are especially beneficial when usedwith drainable pouches designed to be periodically emptied and cleanedfor reuse. Such procedures subject ostomates and/or caregivers tomalodors from the pouches' contents as fecal materials become exposed toair. The malodor problems which the deodorizing agents are intended toreduce are only exacerbated by the tendencies of fecal matter to stickor cling to the inner surfaces of ostomy pouches, thereby prolongingexposure to such malodors during emptying and cleaning procedure.

Apart from such odor problems, users have also encountered difficultieswhen opposite inside surfaces of pouches stick or block together andthereby obstruct the entry and downward movement of fecal matterdischarged into the pouches. Also, feces sometimes cling to opposingpouch surfaces, resulting in a “pancaking” action that impedes downwardtravel of fecal material. It has long been known that users, in theirefforts to reduce such blocking and sticking problems, have sometimesresorted to coating interior pouch surfaces, or at least surfacesopposite from the stoma openings, with anti-sticking agents such asthose commonly found in the home. For example, it is recognized that amaterial widely marketed under the trademark “Pam” has been sprayed byusers into ostomy pouches through the stoma-receiving openings thereofbefore such pouches are adhered to the skin. One disadvantage is thatsuch oily anti-sticking agents are also capable of traveling to the heatseals at the edges of the pouches and become absorbed by the polymericmaterials from which such pouches are formed, thereby weakening the heatseals and increasing the risk of possible rupture of the pouches in use.

Other approaches had been proposed for reducing the coefficient ofsurface friction and possible adhesion between the walls of ostomypouches. Reference may be had to published International application WO03/026540 (Andersen et al.) where a hydrophilic coating is adhesivelyapplied to one or more interior surface portions at the time of pouchmanufacture. One disadvantage is that such a hydrophilic coatingrequires substantial moisture to become hydrated and lubricious, so thebeneficial effects may not be realized unless the waste materialdischarged into a pouch is sufficiently liquid to activate thehydrophilic coating material.

Other patents and published applications disclosing or suggestingvarious approaches for reducing frictional resistance to movement ofwaste material in ostomy pouches are U.S. Pat. Nos. 5,348,546,4,518,388, 5,001,009, and European Patents 0 991 701, and 0 272 816.While these references in one way or another address the issue ofsticking, none is concerned with a material or procedure in which odorneutralizing also occurs simultaneously, or in which an aqueouscomposition has components that coact with each other to achieve andenhance both results.

A main aspect of this invention is to provide an ostomy pouchlubricating deodorant that takes the form of an aqueous solution of awater-soluble lubricating agent and a water-soluble complexing agentcapable of complexing with and neutralizing the odor-causing moleculesof fecal matter. Such a liquid lubricating deodorant is placed into apouch, ordinarily a drainable pouch, by the user. If the ostomyappliance is a one-piece appliance (where the pouch is permanentlyconnected to an adhesive faceplate), then the user of a fresh pouch mayintroduce the recommended amount of liquid lubricating deodorant intothe pouch through its stoma-receiving opening prior to adhering thepouch to the skin. When the pouch thereafter needs draining andcleaning, a process that results in a loss of at least some of theliquid deodorizing/lubricating agent, the desired amount of such agentmay be replenished by introducing it through the pouch's drainageopening. If the appliance is a two-piece appliance (where the pouch isdetachable from the faceplate), the deodorizing lubricant may beintroduced into the pouch either through the pouch's stoma-receivingopening or through its drainage opening if there is one.

In a particularly effective embodiment of the invention, thewater-soluble complexing agent that acts to neutralize the odor-causingmolecules of fecal matter is also a surfactant and, as a surfactant,coacts with the water-soluble lubricating agent to enhance thelubricating effectiveness of the latter. In addition, the liquidlubricating and deodorizing solution may contain other surfactants,humectants, hydrating agents, preservatives, and pH-adjusters orbuffers.

Other features, advantages and objects of the invention will becomeapparent from the following description.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The odor-neutralizing lubricant of this invention essentially comprisesan aqueous solution of a lubricating agent and a complexing agentcapable of neutralizing the odor-causing molecules or fecal matter. Inaddition, the solution includes one or more surfactants and, ideally,the complexing agent also has surfactant capabilities for enhancing boththe lubricating and deodorizing functions of the liquid composition.

The lubricating agent may take the form of an aqueous solution of any ofa number of cellulosic material such as hydroxyethylcellulose (e.g.,“Natrosol 250” from Hercules Incorporated, Wilmington, Del.),hydroxypropylmethylcellulose (“Methocel K15M Premium” from DowChemical), or hydroxypropylcellulose. Aqueous solutions of otherhydrophilic polymers such as polyethylene oxide (“Polyox WSR 1105” fromUnion Carbide) may also be used. Effective results may also be obtainedwith aqueous solutions of polymeric ethers, polyvinyl, alcohol,polyvinylpyrrolidone, hydrophilic colloids and their derivatives,synthetic polymers, polyols and carbomers, and their combinations.

Such lubricating agents are sometimes regarded as thickeners orviscosity-boosting agents; however, they also have the characteristic ofbecoming slippery or lubricious when hydrated sufficiently to formviscous solutions. The extent of dilution, and hence the particularviscosity achieved, is not considered critical as long as thelubricating agent remains a flowable liquid that is capable of wettingand, to a greater or lesser extent, clinging to the inner wall surfacesof an ostomy pouch. The polymeric film materials from which such wallsare formed are well known and may vary considerably but, in general,such films may be multilayer or mono-layer and are liquid and gas(especially odor) impermeable.

The odor neutralizer in preferred embodiments of this invention shouldtake the form of a water-soluble complexing agent capable of complexingwith and neutralizing the odor-causing molecules of fecal matter therebyreducing their concentration in the vapor phase. In performing thatfunction, the complexing agent reacts directly with the odor-causingmolecules, in contrast to serving merely as a perfume or odor-maskingagent. Particularly effective neutralizers are found to be materialssuch as n-ethyl-n-soya-morpholinium ethosulfate, copper citrate, andvegetable protein extracts, but other ionic and nonionic compounds andprotein derivatives and extracts and their combinations may be used.Where the odor neutralizer functions as a surfactant, it also serves toenhance the lubricating effectiveness of the lubricating agent as wellas its own effectiveness as an odor neutralizer. Especially effective inthis regard is n-ethyl-n-soya-morpholinium ethosulfate which functionsas a cationic surfactant and is available under the trademark“Forestall” (Uniqema, New Castle, Del.).

It has also been found that the surfactant or wetting properties areenhanced if a plurality of surfactants are provided in contrast to usingonly a higher concentration of a single surfactant. Such surfactants maybe anionic, cationic, nonionic or amphoteric, or a combination thereof.Examples include, but are not limited to, octoxynol-9, poloxamer 188,sorbitan monolaurate, and alkyl dimethylamine oxide.

Other ingredients include preservatives which prevent microbial growthand add shelf life, for example, methylparaben, ethylparaben,propylparaben, butylparaben, isobutylparaben, phenoxyethanol or a blendof two or more of such preservatives. One such blend found to besuitable is sold under the trademark “Phenonip” by Clariant Corporation,Charlotte, N.C. Any of a variety of other well-known preservatives mayalso be used. Further, it is desireable to include propylene glycol notonly for its solvent hydrating effect but also as a preservative;however, other agents having similar properties may be used, such asglycerine or butylene glycol.

The pH of the aqueous mixture should be neutral, or approximatelyneutral, so, depending on the particular ingredients selected, pHadjusters and buffers may be added as needed, all as well known in theart.

The lubricating deodorant of this invention may be conveniently suppliedto users in a bottle or tube, preferably in a plastic squeeze bottlewith a dispensing closure for ease of application. Alternatively, thelubricating deodorant may be packaged in unit-of-use packets for thebenefit of ostomates at work or traveling who might find such packetsless cumbersome to carry and use than squeeze bottles. The ostomate orcaregiver is instructed to introduce a small amount of the viscousliquid, preferably about 5 ml (1 tsp) and more generally an amountwithin the range of about 3 to 10 ml, into an ostomy pouch eitherthrough the stoma opening of the pouch, before it is adhesively attachedto the skin, or through the drainage opening of the pouch after it hasbeen so attached to the skin. Of course, if the pouch is a closed ornon-drainable pouch, then the only available procedure is the first ofthese. The drain opening (if there is one) is then closed and the userrubs or squeezes the walls of the pouch to coat its inside surfaces withthe liquid lubricating deodorant. Later, when emptying of a drainablepouch is required, the drainage neck of the pouch is unrolled orunclamped and the contents of the pouch are discharged into a toilet,the lubricating deodorant allowing such action to occur by gravity withlittle or no squeezing action by the fingers against the outside wallsurfaces of the pouch being necessary for discharging the pouch'scontents. Thereafter, an additional amount of lubricating deodorant isintroduced into the pouch through its discharge opening to replenish theamount lost during the emptying and cleaning steps.

In general, a lubricating deodorant embodying this invention shouldcontain a weight percentage of cellulosic or other water-solublelubricating agent in the weight percentage range of approximately 0.1 to5.0 percent and a complexing and odor-neutralizing agent within therange of about 0.2 to 7 percent. One or more additional surfactants maybe and preferably are included, having a combined weight of up to about15 percent, preferably about 0.1 to 10 percent. A humectant-solvent suchpropylene glycol may be present in the approximate range of 0.5 to 20percent, and a preservative may account for about 0.03 to 1.0 percent byweight. Purified water is a major component in terms of weight,amounting to about 58 to 98 percent of the solution's total weight.

The following examples further illustrate important features of thisinvention:

EXAMPLE 1

One hundred grams (100 g) of a liquid lubricating deodorant for ostomypouches embodying the invention may be prepared using the followingingredients:

Ingredient Percent W/W Purified Water 75.00 Hydroxyethylcellulose[Natrosol 250 0.70 HHX] Propylene Glycol 3.00 Poloxamer 188 NF [PluronicF-68] 2.00 Octoxynol-9 [Triton X-100] 0.30 n-ethyl-n-soya-morpholinium1.50 ethosulfate [Forestall] Phenonip 0.30 0.5 N sodium hydroxidesolution to 0.2747 bring product pH to 7.00 ± 0.25 range Purified Water(QS. to 100 g batch wt.) 16.9253 TOTAL 100

In a 250 ml beaker quipped with mechanical stirrer is placed 75 g ofpurified water. With stirring, is then added 0.70 ghydroxylethylcellulose. The ingredients are mixed for 15 minutes and thesolution is warmed to 40° C. Heating is discontinued and 1.5 g ofpropylene glycol is added and mixed for 60 minutes. While mixing, 1.5 gof Forestall, 1.5 g of propylene glycol, 2.0 g of poloxamer 188 NF, and0.3 g of Phenonip are added. The pH of the aqueous liquid is thenadjusted to 7.00 (plus or minus 0.25) and purified water is added toproduce a 100 g batch weight. Mixing is continued for an additional 30minutes before packaging the product in 8 oz. bottles.

EXAMPLE 2

Another example of lubricating deodorant solution embodying theinvention may be prepared with the following ingredients:

Ingredient Percent W/W Purified Water 75.00 Hydroxypropymethylcellulose1.20 [Methocel K15M Premium] Propylene Glycol 3.00 Octoxynol-9 [TritonX-100] 0.30 n-ethyl-n-soya-morpholinium 1.50 ethosulfate [Forestall]Phenonip 0.30 0.5 N sodium hydroxide 0.34 Purified Water (QS. to 100 gbatch wt.) QS to 100 g TOTAL 100

The procedure for preparing this solution is essentially the same as setforth in Example 1 except that hydroxypropylmethylcellulose issubstituted for hydroxyethylcellulose as the lubricating agent.

EXAMPLE 3

A further example of a lubricating deodorant embodying the invention,this one using vegetable protein extract as the odor neutralizer, may beprepared as set forth in Example 1 with the following ingredients:

Ingredient Percent W/W Purified Water 75.00 Hydroxyethylcellulose 0.70[Natrosol 250 HHX] Propylene Glycol 3.00 Poloxamer 188 NF 2.00Octoxynol-9 0.30 Phenonip 0.30 Vegetable Protein Extract C 1575 5.00[Carrubba] Sodium Citrate 0.24 Purified Water QS. to 100 g TOTAL 100

EXAMPLE 4

The effectiveness of the lubricating deodorant prepared in accordancewith Example 1 has been tested by using globs or lumps of refried beanspaste to simulate feces and comparing the drop time and drain time ofsuch paste in drainable ostomy pouches with and without addedlubricating deodorant (LD) of this invention. The tests were conductedwith three drainable ostomy pouches (Hollister pouch 3669) with pouch 1being dry (i.e., no lubricating deodorant added) and pouches 2 and 3respectively receiving 5.102 g and 5.452 g of lubricating deodorant.

In conducting the test, the pouches were hung by clamps on a horizontalrod. Measured amounts of lubricating deodorant were then squeezed intoeach of the pouches 2 and 3 through their bottom openings. Thereafter,the bottom drain openings of the pouches were closed using pouch clamps.The pouches were then rubbed gently by hand to spread the lubricatingdeodorant throughout the interiors of the pouches.

Beans paste (Vegetarian Refried Beans, Jewel brand) was then loaded intoa modified syringe. (The modification consisted of cutting a 25 ccdisposable syringe transversely near its needle end so that the openingat the end of the barrel was of the same diameter as the interior of thebarrel.) The beans paste was manually loaded into the syringe from itsfront end using a spatula. The amount of beans paste loaded into thesyringe was recorded and the paste was then discharged into the interiorof each pouch through its faceplate opening. Timing was commenced at themoment the paste was discharged in a pouch and was discontinued when thepaste stopped moving inside that pouch. After three successive loads ofpaste into each pouch, with drop time being measured for each load, thedrain time was determined by carefully removing the bottom clamp andopening the drain opening of the pouch to allow the lump of beans pasteto fall free of the pouch. Drain time was measured from the moment thelower end of the pouch with its drain opening was allowed to hang freeuntil the lump of beans paste dropped from the pouch.

Thereafter, the drain outlet of each pouch was wiped clean and the pouchwas reloaded with an additional mass of beans paste, and the operationsdescribed above were repeated.

The results of these tests with time being indicated in (minutes):(seconds): (hundredths of a second) are as follows:

1 2 3 Dry Pouch Pouch with LD Pouch with LD Amount of LD added   0.0 g 5.102 g  5.452 g 1^(st) Load Wt 21.058 g 21.192 g 21.084 g Amount ofBeans Paste Drop time 0:59:94 0:27:07 0:21:50 2^(nd) Load Wt 21.218 g21.115 g 21.113 g Amount of Beans Paste Drop time 0:16:41 0:04:320:01:91 3^(rd) Load Wt 21.040 g 21.129 g 21.055 g Amount of Beans PasteDrop time 0:21:40 0:04:72 0:01:31 Drain time Did not fall 0:12:150:08:75 by itself even at 5 min. Had to squeeze out. Messy to clean thepouch outlet. Amount of LD reloaded   0.0 g  5.970 g  5.388 g 1^(st)Load Wt  21.07 g 21.369 g 21.184 g Amount of Beans Paste Drop time01:15:53  0:39:78 0:00:88 2^(nd) Load Wt 21.416 g 21.246 g 21.028 gAmount of Beans Paste Drop time 0:07:44 0:04:22 0:01:25 3^(rd) Load Wt21.125 g 21.165 g 21.113 g Amount of Beans Paste Drop time 0:47:000:01:18 0:01:56 Drain time Did not fall 0:32:56 0:14:00 by itself at 5min. Had to squeeze it out.

EXAMPLE 5

To test the deodorizing effectiveness of the lubricating deodorantsprepared in accordance with Examples 1 and 3, such solutions werecompared with results produced by a known copper citrate liquiddeodorizer (Hollister M9 Drop Deodorizer) capable of complexing withodor-causing molecules and prepared in accordance with Maurer U.S. Pat.No. 6,200,939. The M9 odor neutralizer is known to be effective inreducing or neutralizing malodors produced by a wide variety ofmaterials and is marketed as a liquid that may be added in drop form toostomy pouches for the purpose of eliminating or reducing fecal odors.

The test was conducted as follows: Weighed 2 g of chopped onions wereplaced in each of 12 jars, and lids were then attached. (Chopped onionsare widely used in test procedures involving fecal odors because sulfurcompounds are largely responsible for the odors of both.) The jars weredivided into three groups (A, B and C) with each jar being labeled withan alphanumeric code. In each group, one of the jars was kept untreatedwith a deodorant for purposes of serving as a control. The other threejars in each group were treated with three different deodorantformulations, one being the lubricating deodorant of Example 1 (LD Ex.1), the second with the lubricating deodorant of Example 3 (LD Ex. 3)and the third with the commercial Drop Deodorizer marketed as M9. In thecase of M9, nine drops were added to each jar based on the product'slabel instructions.

Twenty adult human subjects participated in the tests, all of which werecarried out under a fume hood. The hood fan was turned on for briefperiods between each sample sniffing (prior to opening a jar) to makesure that there would be no residual odor in the atmosphere that mightinterfere with the test.

The participants were asked to remove the lid of each jar, sniff thecontents, and score it for onion odor on a scale of 0 to 4, with score“0” representing No Odor and score “4” representing a Strong Odor.Between each evaluation, the participants sniffed a jar containing freshground coffee to clear the nose of any residual onion odor prior toevaluating the next test jar.

The scores of these tests are set forth in the chart below. The chartreveals that jars containing the lubricating deodorant of Example 1generally produced less detectable odor than those containing thelubricating deodorant of Example 3 or the M9 deodorant. There was nostatistical difference in performance between the jars containing thecommercial M9 Drop Deodorizer and those containing the lubricatingdeodorizer using vegetable protein extract as set forth in Example 3.

LD Ex. 1 LD Ex. 3 M9 Partici- Partici- Partici- pant A B C pant A B Cpant A B C 1 2 1 1 1 1 1 2 1 2 2 2 2 2 2 2 2 3 2 2 2 3 2 2 3 3 3 3 3 4 32 3 1 2 2 4 0 0 1 4 1 2 0 4 2 1 2 5 2 1 1 5 2 4 3 5 2 1 2 6 2 2 2 6 4 33 6 3 3 4 7 1 1 1 7 3 2 2 7 1 1 2 8 0 1 0 8 1 2 1 8 2 0 1 9 1 2 2 9 2 22 9 1 3 2 10 0.5 2 1 10 2 3 2 10 1 3 1 11 1 0 1 11 1 0 0 11 1 1 0 12 1 12 12 2 2 3 12 1 0 1 13 0 0 0 13 0 3 1 13 2 1 1.5 14 1 1 0.5 15 3 3 3 142 2 0.5 15 2 1 2 15 3 2 2 15 3 3 3 16 3 3 3 16 2 2 4 16 3 2 2 17 3 2 217 3 2 1 17 3 3 3 18 1 0 0 18 2 1 1 18 1 3 2 19 0 0 0 19 4 2 2 19 2 2 020 1 1 2 20 3 3 3 20 1 2 1

While in the foregoing we have disclosed embodiments of the invention inconsiderable detail for purposes of illustration, it will be understoodby those skilled in the art that many of these details may be variedwithout parting from the spirit and scope of the invention.

1. A method for treating the interior of an ostomy pouch forsimultaneously lubricating the interior surfaces thereof and providingan agent for neutralizing fecal odors developed in the pouch, comprisingthe steps of introducing into the pouch prior to use thereof a quantityof a lubricating deodorant in the form of an aqueous solution containingboth a water-soluble lubricating agent and a water-soluble complexingagent capable of complexing with and neutralizing the odor-causingmolecules of fecal matter, and then pressing and squeezing the walls ofthe pouch to distribute said lubricating deodorant solution throughoutthe pouch and into full contact with the interior surfaces thereof. 2.The method of claim 1 in which the amount of lubricating deodorantintroduced into said pouch is within the range of about 3 to 10 ml. 3.The method of claim 2 in which the complexing agent of said lubricatingdeodorant is also a surfactant that enhances the ability of saidlubricating agent to wet the interior surfaces of said ostomy pouch. 4.The method of claims 1 or 2 in which said lubricating agent iscellulosic.
 5. The method of claims 1 or 2 in which said lubricatingagent and said complexing agent have percentages of total solutionweight of about 0.1 to 5.0 percent and about 0.2 to 7 percent,respectively.